Clinical development study teams must contend with many challenges and complexities in developing and executing clinical trials. Some challenges are directly related to, or are impacted by, laboratory considerations. For example, study teams are asked to evaluate decentralized trial designs, informed consent tracking, and future use of patient samples. They are asked to work with niche laboratories, point of care (POC) laboratory devices, and other technologies to enable patient-centric trials.
We have deployed innovative solutions, and are developing various initiatives, to support our customers and their study teams. These initiatives are categorized as 1) supporting decentralized trials innovation, 2) sample and consent tracking innovation, 3) technology innovation, and 4) operational and scientific innovation.
Near Patient Collection (NPC)
To support decentralized trials, and to enable convenience for patients, we have partnered with mobile nurse and phlebotomy companies to support in home specimen collection, as well as specimen collection at Quest Diagnostic patient service centers (PSCs) in the United States. We have managed laboratory testing for dozens of studies utilizing Near Patient Collection services across many therapeutic areas.
Self-collection of Specimens
Self-collection of specimens involves sending specimen collection devices directly to patients. Patients collect their own specimens and send the devices with the specimens to a laboratory for testing. At Q2 Solutions, we are partnering with several self-collection device manufacturers to build a validated menu to support these collection modalities. We are also exploring options for centrifugation to be used in conjunction with self-collection devices.
Direct to Patient (DTP) Kit Shipments
As self-collection and home healthcare become more prevalent in clinical trials, so does the interest in shipping specimen collection kits directly to patients’ homes. The Q2 Solutions DTP Kit Distribution service enables specimen collection kits to be shipped directly to patients on behalf of clinical trial investigators, while taking great care to properly manage sensitive patient protected health information (PHI).
Sample and Consent Tracking
Clinical trials today involve sophisticated sample collection and analysis to enable patient segmentation and to demonstrate safety and efficacy of the drug under study. With proper consent, samples can also be used to provide researchers with greater insights into biological pathways and related diseases in future studies. Following sample/consent tracking and biobanking best practices is integral to clinical trials, translational research and precision medicine. For more information visit our Biospecimen and Consent Management webpage.
Blockchain for Sample Tracking
We have piloted the use of blockchain technology for sample tracking. Our lessons learned are available via a Blockchain whitepaper.
Laboratory Trials Management System (LTMS)
The Laboratory Trials Management System manages laboratory process for clinical trials to enhance the following:
AI Protocol Reading
We have piloted automated extraction of meaningful data from study protocol documents via the use of artificial intelligence and machine learning. This approach can vastly improve the central laboratory study set-up process, among many other potential use cases.
AI Local Lab Data Management
To support customers who, due to certain circumstances, require local labs to perform testing for their clinical trial patients, we have developed an automated approach to extract lab values from reports coming in from local labs and automated processes to incorporate those results into our master data management systems.
Leveraging optical character recognition & Natural Language Processing platforms, we can provide a scalable and systematic approach to extracting and normalizing test result values irrespective of the performing lab.
At Q2 Solutions, we have a dedicated digital innovation department focused on driving improvements in efficiency and quality generating new customer offerings. Our process includes internal pilots, as well as joint engagements with customers to explore exciting possibilities.
Here are some examples of the dozens of projects managed by the digital innovation team.
Incorporation of laboratory point of care (POC) testing in clinical trials is increasing. POC devices have been deployed at investigator sites to screen and enroll a patient in a single visit, help reduce screen failure rates via a pre-screening step, and provide for results more rapidly than local labs. However, in these examples POC devices were not integrated with the clinical trial laboratory, and the data was not used for regulatory submissions. We have connected POC devices to our central laboratory systems to enable viewing of laboratory reports by medical monitors and data transfers to study teams. Our lessons learned are available via our Point of Care article in Applied Clinical Trials.
Electronic Histology and Pathology Reports (ePROC and ePRF)
Traditionally, Histology and Anatomic Pathology reporting has been a very paper-based, manual process. We automated the process via a proprietary information management software solution. Moving to electronic sample processing instructions (ePROC) and an electronic pathology report form (ePRF) system provides a better way to assure data quality. Benefits include the following:
Flow Cytometry Result Reporting Automation
Flow cytometry result calculation and reporting was historically a manual process, with time-consuming spreadsheets and paper-based processes. We automated our result reporting process via a proprietary information management software solution. This automation project coincided with our global implementation of the next generation flow cytometry Cytek™ Aurora platform, which generates considerably more data than traditional flow cytometers.
Next Generation Flow Cytometry
In an effort to continuously provide industry-leading laboratory testing solutions and cutting-edge technologies to drug developers and patients, we have adopted next generation flow cytometry systems in its eight laboratories around the globe covering North America, Europe, Asia Pacific and China, through a multi-year collaboration with Cytek™ Biosciences. Learn more via a Next Generation Flow Cytometry press release.